Recalls / Class II
Class IID-0778-2021
Product
MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de Mexico, CDMX, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00417 8
- Affected lot / code info
- Lot No: GV4420205 Best By, 5/21/2022
Why it was recalled
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Recalling firm
- Firm
- Global Sanitizers LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5979 S Valley View Blvd, N/A, Las Vegas, Nevada 89118-3111
Distribution
- Quantity
- 50,000 bottles
- Distribution pattern
- Product Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2021-05-12
- FDA classified
- 2021-08-30
- Posted by FDA
- 2021-09-08
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0778-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.